Hepatic Impairment Sample Clauses
The Hepatic Impairment clause defines how a contract, policy, or medical protocol addresses situations involving individuals with reduced liver function. It typically outlines specific considerations, adjustments, or restrictions for the use of certain medications, treatments, or obligations when a party is known to have hepatic impairment. For example, it may require dose modifications, additional monitoring, or exclusion from certain activities based on the severity of liver dysfunction. The core purpose of this clause is to ensure safety and compliance by adapting procedures to the unique risks and needs associated with impaired liver function.
Hepatic Impairment. Because acetaminophen is extensively metabolized by the liver, the use of APADAZ in patients with severe hepatic impairment or severe active liver disease is contraindicated. The pharmacokinetics and tolerability of APADAZ in patients with impaired hepatic function have not been studied [see Contraindications (4), Use in Specific Populations (8.6)].
Hepatic Impairment. The effect of hepatic impairment on the pharmacokinetics of APADAZ has not been determined. Patients with hepatic impairment may have higher plasma concentrations than those with normal function. Use a low initial dose of APADAZ in patients with hepatic impairment or active liver disease and monitor closely for adverse events such as respiratory depression and hepatotoxicity [see Warnings and Precautions (5.2 and 5.5)].
Hepatic Impairment. As binimetinib is primarily metabolised and eliminated via the liver, patients with moderate to severe hepatic impairment may have increased exposure. Results from a dedicated clinical study with binimetinib only indicate similar exposures in patients with mild impairment (Child-▇▇▇▇ Class A) and subjects with normal liver function. A two-fold increase in total binimetinib exposure (AUC) was observed in patients with moderate (Child-▇▇▇▇ Class B) and severe (Child-▇▇▇▇ Class C) hepatic impairment (see section 4.2). This increase expends to three fold in both moderate and severe hepatic impairment when considering unbound binimetinib exposure (see section 4.2).
Hepatic Impairment. In patients with severe hepatic impairment, the dose of BYFAVO should be carefully titrated to effect. Depending on the overall status of the patient, lower frequency of supplemental doses may be needed to achieve the level of sedation required for the procedure. All patients should be monitored for sedation-related cardiorespiratory complications.
Hepatic Impairment. Pharmacokinetics of a 2 mg eszopiclone dose were assessed in 16 healthy volunteers and in 8 subjects with mild, moderate, and severe liver disease. Exposure was increased 2-fold in severely impaired patients compared with the healthy volunteers. Cmax and tmax were unchanged. The dose of LUNESTA should not be increased above 2 mg in patients with severe hepatic impairment. No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. LUNESTA should be used with caution in patients with hepatic impairment. (See DOSAGE AND ADMINISTRATION.)
Hepatic Impairment. In patients with severe cirrhosis (Child ▇▇▇▇ score Class C), limit the dose to 2 tablets a day (see section 5.2). In patients with chronic alcoholism, whether they do not have cirrhosis or have mild or moderate cirrhosis, no dose adjustment is necessary (see section 5.2).
Hepatic Impairment. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, these drugs should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.